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Oxytocin, Carbetocin and Misopristol for Treatment of Postpartum Hemorrhage: A Multicentric Randomized Trial

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ClinicalTrials.gov Identifier: NCT01600612
Recruitment Status : Unknown
Verified May 2013 by Salah M Rasheed, Sohag University.
Recruitment status was:  Recruiting
First Posted : May 17, 2012
Last Update Posted : May 31, 2013
Sponsor:
Collaborator:
Information provided by (Responsible Party):

Study Description
Brief Summary:

Postpartum hemorrhage (PPH) is the leading cause of maternal death worldwide, with an estimated mortality of 140 000 per year. Uterine atony is one of the most important causes of PPH. The traditional treatment of which is the use of uterotonic agents. Oxytocin is the most conventional drug which was proved effective. However, it has the shortcomings of short half life and the necessity of intravenous administration. Misopristol, and more recently Carbetocin were introduced for treatment of atonic PPP not responding to Oxytocin.

Aim of the study is to evaluate the effectiveness of Carbetocin, Misopristol, and Oxytocin for treatment of atonic PPH.


Condition or disease Intervention/treatment
Postpartum Hemorrhage Drug: carbetocin Drug: misopristol Drug: oxytocin

Detailed Description:

The study will be conducted at the departments of Obstetrics and Gynecology of Sohag, Qena, Al Azhar, and Assuit university hospitals, Egypt. All patients with atonic PPH who delivered vaginally will be invited to participate in the study. Patients who delivered by caesarean section, with retained placenta, with traumatic PPH, associated coagulopathy and those refused to participate in the study will be excluded. The patients will be randomly categorized into 3 groups; the first (n = 100) will receive 30 IU oxytocin intravenously; the second (n = 100) will receive 600 ug misopristol sublingually; the third (n = 100) will receive 100 ug Carbetocin IV. The randomization will be done using opaque sealed envelops containing computer-generated codes. The primary outcome of the study is cessation of bleeding which will be judged by visual inspection of the blood loss by the trialist and by loss of < 300 mL of blood during the first hour after enrollment. The secondary outcomes are time of control of bleeding (minutes), amount of blood loss till control of bleeding (mL), changes in the hemoglobin levels (gm) before and after treatment, Changes in the hematocrite values (%) before and after treatment, the use of additional uterotonic drugs, the rate of complications (%), and the necessity for surgical intervention, and the cost of each medication.

Written consent will be obtained from all participants and approval from the local institutional ethical committee will be included.


Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 300 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Oxytocin, Carbetocin and Misopristol for Treatment of Postpartum Hemorrhage: A Multicentric Randomized Trial
Study Start Date : September 2012
Estimated Primary Completion Date : June 2013
Estimated Study Completion Date : July 2013

Resource links provided by the National Library of Medicine

Drug Information available for: Oxytocin
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Active Comparator: Oxytocin
30 IU of oxytocin will be given intravenously to patients with atonic postpartum hemorrhage
Drug: oxytocin
30 IU of oxytocin will be given intravenously to patients with atonic postpartum hemorrhage
Active Comparator: carbetocin
10 ug of carbetocin will be given intravenously to patients with atonic postpartum hemorrhage
Drug: carbetocin
10 ug of carbetocin will be given intravenously to patients with atonic postpartum hemorrhage
Other Name: pabal
Active Comparator: misopristol
600 ug of misopristol sublingually will be given intravenously to patients with atonic postpartum hemorrhage
Drug: misopristol
600 ug of misopristol will be given sublingually to patients with atonic postpartum hemorrhage
Other Name: Misotac


Outcome Measures

Primary Outcome Measures :
  1. control of postpartum hemorrhage [ Time Frame: within 20 minutes of administration ]

Secondary Outcome Measures :
  1. time of control of bleeding, amount of blood loss till control of bleeding, changes in the hemoglobin and hematocrite levels, use of additional uterotonic drugs, necessity for surgical intervention, and the rate of complications. [ Time Frame: 24 hours ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • primary atonic postpartum hemorrhage after vaginal delivery

Exclusion Criteria:

  • Patients who delivered by caesarean section
  • Retained placenta
  • Traumatic postpartum hemorrhage
  • Associated coagulopathy
  • Chronic medical illness (hepatic , renal diseases)
  • Refusal to participate in the study.
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01600612


Contacts
Contact: Salah M Rasheed, MD 01224653702 salahrasheed67@yahoo.com

Locations
Egypt
Sohag university Recruiting
Sohag, Egypt, 1224
Contact: Mostafa M Abdel Khalek, MD    01226534893    elgalawy@yahoo.com   
Principal Investigator: Salah M Rasheed, MD         
Sponsors and Collaborators
Sohag University
Al-Azhar University
Investigators
Study Director: Salah M Rasheed, MD Department of Obstetrics and Gynecology, Sohag university, Egypt
Study Chair: magdy M Amin, MD Department of obstetrics and Gynecology, Sohag university, Egypt
Principal Investigator: Ahmed H Abd-Ella, MD Department of obstetrics and Gynecology, Qena university, Egypt
Principal Investigator: Ahmed M Abo Elhassan, MD Department of obstetrics and Gynecology, Assuit university, Egypt
Principal Investigator: Mazen A El Zahry, M.D. Department of Obstetrics and Gynecology, Al Azhar university, Egypt
More Information

Responsible Party: Salah M Rasheed, Dr, Sohag University
ClinicalTrials.gov Identifier: NCT01600612     History of Changes
Other Study ID Numbers: salah-1
First Posted: May 17, 2012    Key Record Dates
Last Update Posted: May 31, 2013
Last Verified: May 2013

Keywords provided by Salah M Rasheed, Sohag University:
postpartum hemorrhage, oxytocin, carbetocin, misopristol

Additional relevant MeSH terms:
Hemorrhage
Postpartum Hemorrhage
Pathologic Processes
Obstetric Labor Complications
Pregnancy Complications
Puerperal Disorders
Uterine Hemorrhage
Oxytocin
Carbetocin
Oxytocics
Reproductive Control Agents
Physiological Effects of Drugs